UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052595 |
|---|---|
| Receipt number | R000060016 |
| Scientific Title | Characteristics of hospitalized patients who recognize the effectiveness of infection prevention instruction in psychiatry |
| Date of disclosure of the study information | 2023/10/24 |
| Last modified on | 2025/01/02 14:02:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Characteristics of hospitalized patients who recognize the effectiveness of infection prevention instruction in psychiatry
Acronym
Characteristics of hospitalized patients who recognize the effectiveness of infection prevention instruction in psychiatry
Scientific Title
Characteristics of hospitalized patients who recognize the effectiveness of infection prevention instruction in psychiatry
Scientific Title:Acronym
Characteristics of hospitalized patients who recognize the effectiveness of infection prevention instruction in psychiatry
Region
| Japan |
Condition
Condition
Schizophrenia
Mood Disorders
bipolar disorder
attention deficit hyperactivity
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct a study session on infection prevention for inpatients of the psychiatric department of Hospital A and observe changes in patients' infection prevention behavior before and after the study session. We will reveal the differences in the characteristics of patients who did and did not recognize the effectiveness of those instructional sessions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight of rubbing hand sanitizer one week after study session
Hand washing time
hand sanitizing time
Unwashed hands score using the Handwash Checker hand evaluation chart
Key secondary outcomes
Age
Gender
Diagnosis, duration of illness
Length of hospital stay
Psychiatric symptoms
GAF
Awareness of infection prevention behavior (questionnaire)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Subjects' age, gender, diagnosis, and length of hospital stay were obtained from their medical records. Within one week from the date of admission, a questionnaire regarding hand hygiene was administered, including the number of hand washings, hand disinfection, and frequency of wearing masks and ventilation.The subjects performed hand washing and hand disinfection, and the unwashed areas of hand washing were scored. Using a glitter bug, the lotion remaining on both hands after hand washing was counted for each hand area using an evaluation chart.The weight of the hand sanitizer was measured.
One week after the first hand hygiene, a study session on infection control was conducted using a video. The same questionnaire and hand hygiene were administered to the subjects as in the first session, and hand sanitizer weights were measured.
One week after the study session, we administered the same questionnaire and hand hygiene to the subjects as in the first session and measured hand sanitizer weights.
After data collection, the subjects were divided into two groups, those who benefited from the study session and those who did not. Subjects who showed an effect were those whose hand washing time and hand sanitizing time after the study session were both 15 seconds or longer, and the number of unwashed areas decreased from before the study session, in accordance with the CDC guideline. The two groups were compared using chi-square test, Wilcoxon test, and Wilcoxon signed-rank sum test based on basic attributes, hand hygiene time before and after the study session, number of unwashed areas, and questionnaire items. All tests were judged statistically significant at p-value of less than 0.05.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. voluntary hospitalized patients over 18 years of age who are admitted to the Psychiatry Department of Hospital A and are expected to be hospitalized for at least 3 weeks.
2. patients who have not been diagnosed with dementia or obsessive-compulsive disorder
3. patients who can consent to this research plan
Key exclusion criteria
1. patients with a diagnosis of dementia or obsessive-compulsive disorder
2. Patients who are hospitalization for medical care and protection or Involuntary admission to hospital
3. patients whom the attending physician determines are not appropriate as research subjects
4. patients with an allergy to alcohol
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nakao |
Organization
Kyushu University
Division name
Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
0926411151
nakao.tomohiro.275@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Anna |
| Middle name | |
| Last name | Kono |
Organization
Kyushu University
Division name
Nursing Department West Wing 1st floor ward
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
0926411151
Homepage URL
kono.anna.631@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Anna Kono
Funding Source
Organization
Kyushu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital Institutional Review Boards / Ethics Committees
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
Results
Comparing the time for each of the three hand hygiene sessions between the two groups, a significant difference was found in the third hand washing time and in the second hand sanitizing time. Next, hand hygiene time and frequency, number of unwashed areas, and amount of hand sanitizer used were compared before and after the study session. The number of hand hygiene sessions per day increased in both groups, but significantly more in the effective group than in the ineffective group.
Results date posted
| 2025 | Year | 01 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age: 19-55
Gender: 9 males, 10 females
Diagnoses: depression in 11 patients, bipolar disorder in 3 patients, schizophrenia in 3 patients, panic disorder in 2 patients
Duration of illness: 2 months to 32 years
Length of hospital stay: 31-86 days
GAF: 61 to 85
Participant flow
Of the 23 subjects who gave consent for the study, 19 were able to participate in all three hand hygiene sessions. Twelve were in the effective group and seven were in the ineffective group.
Adverse events
No adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060016
